The effect of an adapted Mindfulness-Based Stress Reduction program on mental health, maternal bonding and birth outcomes in psychosocially vulnerable pregnant women: a study protocol for a randomized controlled trial in a Danish hospital-based outpatient setting.
Sine Skovbjerg, Antonia Sumbundu, Michelle Kolls, Anette Kjærbye-Thygesen, L O Fjorback
BMC Complementary Medicine and Therapies October 14, 2023 DOI: 10.1186/s12906-023-04194-3 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 240 |
| Population | Pregnant women with a preconception history of mental disorders or psychosocial vulnerabilities recruited from an obstetric ambulatory clinic at Copenhagen University Hospital, Hvidovre, Denmark |
| Intervention | Mindfulness-Based Stress Reduction (MBSR) |
| Duration | Nine months post-randomization |
| Topics | Meditation |
| Keywords | Mental disorders Mental health Mindfulness-based stress reduction Motivational interviewing Pregnancy Psychosocial vulnerability Self-compassion |
| Citations | 11 |
| Registration | NCT05300646 |
| Key findings | The protocol aims to test whether an adapted MBSR program as add-on to usual care improves mental wellbeing compared to usual care alone in psychosocially vulnerable pregnant women. |
Abstract
Stress and mental disorders in pregnancy can adversely affect the developing fetus. Women with a preconception history of mental disorders or of psychosocial vulnerabilities are at increased risk of experiencing perinatal stress or mental health problems. Mindfulness-Based-Stress-Reduction (MBSR) is an acceptable intervention for pregnant women and has a growing evidence-base with meta-analyses consistently pointing to reductions in symptoms of stress, anxiety and depression. This study protocol aim to address the need for a wider array of evidence-based and non-pharmacological options during pregnancy to reduce stress and improve mental health in a psychosocially highly vulnerable group of women. Pregnant women with a preconception history of mental disorders or psychosocial vulnerabilities (n = 240) will be recruited from an obstetric ambulatory clinic at Copenhagen University Hospital, Hvidovre, Denmark. Recruitment for the study began in March 2022 and will continue until the desired number of participants is reached. Consenting pregnant women will be randomized to one of two study arms, an adapted MBSR program as add on to usual care or usual care alone. The primary outcome is mental wellbeing at nine months post-randomization. Secondary and exploratory outcomes include stress, anxiety, depression, and maternal antenatal attachment, experience of childbirth, delivery and mode of delivery. Mindfulness and self-compassion are examined as possible mediators of the effect on outcomes. Teaching the skills of mindfulness meditation to a psychosocially vulnerable group of pregnant women could prove a viable and non-pharmacological approach to improve mental health and wellbeing during pregnancy, reduce stress and support the transition to parenthood. Mindfulness-Based Stress Reduction does not target a particular group, and results from the study is thus of potential relevance for pregnant women in general as a means of reducing stress and improving perinatal mental health and wellbeing. ClinicalTrials.gov: NCT05300646 . Registered March 29, 2022.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cited by 3
- Mindfulness-Based Stress Reduction adapted to pregnant women with psychosocial vulnerabilities - a randomized feasibility trial in a Danish hospital-based outpatient setting. Pilot and Feasibility Studies June 21, 2025
- Reconnecting with the Self and Fetus through Mindfulness: Supporting Inner Balance and Bonding during Pregnancy Psikiyatride Güncel Yaklaşımlar April 14, 2026
- "This course has made it easier for me to embrace myself and my child": A qualitative study of an adapted mindfulness-based stress reduction course for pregnant women with psychosocial vulnerabilities. PLOS mental health 2025
Cites 16
- Construct Validity of the Five Facet Mindfulness Questionnaire in Meditating and Nonmeditating Samples Assessment February 29, 2008
- What defines mindfulness-based programs? The warp and the weft Psychological Medicine December 29, 2016
- The Empirical Status of Mindfulness-Based Interventions: A Systematic Review of 44 Meta-Analyses of Randomized Controlled Trials Perspectives on Psychological Science February 16, 2021
- Mindfulness Meditation and Psychopathology Annual Review of Clinical Psychology December 11, 2018
- Prevalence of meditation-related adverse effects in a population-based sample in the United States Psychotherapy Research June 2, 2021
and 11 more in the library